Real World Evidence (RWE): different needs for one goal

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1 How to address various stakeholder's perspectives towards the generation of reliable RWE to enhance the value of your product Course language: English 110 Early Bird discount for enrolment by 11 th September 2018 Hilton Zurich Airport Hohenbuehlstrasse 10 - Zurich, Switzerland Tuesday 09 October :00-18:00 Taking part in our training courses, Michela Rimondini e Monia Dardi Il Vaso di Fiori you support "The Vase of Flowers" project For additional information: +39 (0)

2 Introduction Real-world evidence should be incorporated throughout all the product s lifecycle to ensure a significant value during its launch and commercialization. An integrated patient-centric perspective among different stakeholders and a focus on continuous evidence generation is the way forward for the life science industry. This course will be mainly focused on providing methods to successfully: Identify & prioritize the different RWE needs throughout the product lifecycle. Apply the observational approach to evaluate unmet needs during the clinical development as well as the impact of the drug utilization in the real-world (i.e. patient s perceptions, effectiveness, safety and benefit in diverse environments and specific patients subset). Adopt a multidisciplinary approach to design optimized RWE projects that combine multiple stakeholders needs (i.e. Medical Affairs, Market Access and Clinical Development) to generate clinical evidence aligned with the product strategy and its lifecycle stage. Who should attend? The course is for professionals working in Medical Affairs, Market Access, Drug Development/Clinical Research, Real World Evidence generation, HEOR of pharmaceutical and biotech companies. Teaching methods Focused lessons, discussions and workshops.

3 Programme The course programme will focus on the following topics: RWD and RWE: current strategic context Methods for RWE generation Study designs RWE to support the value of the product over the whole lifecycle Potential RWE use cases Workshop and discussion Agenda 9:00-9:30 9:30 11:00-11:15 13:00 15:45-16:00 18:00 Participants registration Course commences Coffee Break Lunch Coffee Break Q&A and conclusion Participant experience Some familiarity with biomedical research/drug development is recommended. At the end of the training, you will be able to: Plan RWD projects able to support the value proposition of your product during the whole lifecycle Adopt a tested multi-step technique to design your RWD project, based on the Company s strategy and multi-stakeholders need leading the entire product development and commercialization

4 Lecturer's Bio Giovanni Fiori, Scientific Director at MediNeos Observational Research A PhD in Human Populations Biology (Bologna University), Giovanni has also a master s degree in Public Health from the Catholic University Sacro Cuore (Rome). He managed epidemiological research campaigns in the framework of large international cooperation programs in Central Asia. Since its foundation, he is the Scientific Director of Medineos (previously MediData), in charge to define the strategy for designing and conducting more than 120 local and international studies collecting Real World Data for Life Science Industries and no-profit organizations. Since 2005 he has been coordinating the Observational Studies Working Group of the Society for Applied Pharmacological Sciences where he has also been a member of the Board of Directors. He is the chairman of EUCROF (European CRO Federation) Late Phase working group. He teaches regularly at the Master in Clinical Research of Milano Bicocca University. Invited speaker at several congresses, he has been authored or co-authored over one hundred scientific papers and articles. Christian Amici, Clinical Project Portfolio Manager After graduating in Pharmaceutical Biotechnology, he obtained a master's degree in International Health Care Management, Economics and Policy at Bocconi University (Milan). He began his work experience in MediNeos in 2009 as Clinical Research Associate and later as a Study Designer. Since 2014 he has covered the role of Clinical Project Portfolio. Christian has a consolidated experience in: observational research international and local project management and account public speech epidemiology Participants will get a 10% discount for the registration to the EUROPEAN EPIDEMIOLOGICAL FORUM 2018 October 8th, Zurich

5 TO REGISTER FOR THE COURSE YOU CAN FILL IN AND SEND THE REGISTRATION FORM OR DIRECTLY REGISTER ONLINE: REGISTRATION FEES: Methods of payment Early bird: 880,00* until 11/09/2018 Ordinary: 990,00* Freelance Academy Public Administration: 460,00* *For Italian companies: + 22% VAT The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. The full amount must be paid on registration to EasyB s.r.l by bank transfer or by credit card. If paying by bank transfer please attach proof of payment to the registration form. Bank transfer payable to: EasyB S.r.l. Via Roma, Alzano Lombardo (BG) P. IVA Banco BPM - Filiale di Carobbio Degli Angeli IBAN: IT81 F SWIFT CODE: BAPPIT21AY5 For additional information: Secretarial office Phone Fax Mail LS Academy +39 (0) Please fill in and send: (+39) Surname Company Address City Tel. Special Dietary Requests Invoicing details Company name Address Mail address (If different) City VAT number Terms & conditions Name Job title Post code Fax. Post code or register online. Terms of payment The registration fee must be paid at the time of registration. Confirmation of course admission will be given on receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants. Cancellation Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the course date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities. LS Academy reserves the right not to accept registrations not compatible with the event s target audience. The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course. In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT ) will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for sending newsletters, for marketing purposes (sending advertising material, market research and commercial communication) and for communication purposes to third parties (lecturers), also for marketing goals. You can read the complete information, including your rights and the procedures for the exercise of the same, following this link. LSACADEMY.com Date Signature